D-0301-2021 Class II Terminated
FDA drug recall D-0301-2021 was initiated by Akorn, Inc. on March 8, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing The recall status is terminated (terminated August 9, 2022). Affected quantity: 8,183 unit dose cups.
Recall Details
- Product Type
- Drugs
- Report Date
- March 24, 2021
- Initiation Date
- March 8, 2021
- Termination Date
- August 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,183 unit dose cups
Product Description
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Distribution Pattern
Nationwide USA
Code Information
Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022